LithoVue Elite Ureteroscope for Kidney Stones

(LVE Trial)

Recruiting at 5 trial locations

Overseen By Naeem Bhojani, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Pregnancy, Nephrostomy tube, Hydronephrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Flexible ureteroscopy has become the main surgical treatment for kidney stone disease. The procedure uses many types of ureteroscopes (disposable and non-disposable). Currently we are using the LithoVue Single-Use Digital Flexible Ureteroscope. The Health Canada approved LithoVue Elite disposable flexible ureteroscope will now offer novel pressure sensory capacity. In order to evaluate the new ureteroscopy we will be conducting a prospective multi-institution study in order to determine the main features, capacity and abilities of the new scope. We will evaluate the impact of intra renal pressure on pain, quality of life and possible infectious complications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the LithoVue Elite Ureteroscope treatment for kidney stones?

Research shows that the LithoVue single-use digital flexible ureteroscope is effective in treating kidney stones, offering good image quality and maneuverability. It also eliminates the need for costly repairs and reduces procedural delays, making it a practical choice for high-volume centers. ^{1 2 3 4 5}

Is the LithoVue Elite Ureteroscope generally safe for use in humans?

The LithoVue Elite Ureteroscope, a single-use device, has been used in procedures for kidney stones and compared to reusable ureteroscopes. While specific safety data is limited, its use in humans has been documented without reports of significant safety concerns. ^{1 2 4 5 6}

How is the LithoVue Elite treatment for kidney stones different from other treatments?

The LithoVue Elite is a single-use digital flexible ureteroscope, which means it is used once and then disposed of, eliminating the need for costly repairs and reprocessing associated with reusable scopes. It offers improved flexibility and image quality, making it particularly effective for accessing challenging areas in the kidney, such as the lower pole, during stone removal procedures. ^{1 2 4 5 6}

Research Team

Naeem Bhojani, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

This trial is for adults over 18 with kidney stones that are not causing a blockage and measure 2 cm or less in total diameter. It's not for those under 18, pregnant individuals, people with unusual kidney shapes, severe swelling of the kidneys, or those who have a tube inserted to drain their kidney.

Inclusion Criteria

I am older than 18 years.

I am scheduled for a procedure to remove kidney stones using lasers.

I have a kidney stone smaller than 2 cm and am getting a flexible ureteroscopy.

Exclusion Criteria

I have kidney abnormalities.

I am under 18 years old.

You are pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Preoperative assessments including imaging, questionnaires, and baseline measurements

1 day

1 visit (in-person)

Treatment

Ureteroscopy with LithoVue Elite ureteroscope and laser lithotripsy

1 day

1 visit (in-person)

Postoperative (1-2 weeks)

Stent removal and follow-up assessments

1-2 weeks

1 visit (in-person or virtual)

Follow-up

Standard of care imaging and assessment of stone-free rate and quality of life

4-8 weeks

1 visit (in-person)

Treatment Details

Interventions

• LithoVue 2.0
• LithoVue Elite

Trial Overview The study is testing the LithoVue Elite ureteroscope—a new disposable scope with pressure sensing abilities—during surgery to remove kidney stones using lasers. The goal is to see how it affects pain levels, quality of life, and risk of infection.

Participant Groups

Group I: Ureteroscopy (URS) with the LithoVue Elite disposable flexible ureteroscope Experimental Treatment 1 Intervention

Ureteroscopy will be done using the LithoVue Elite disposable flexible ureteroscope instead of the satandard ureteroscope

LithoVue 2.0 is already approved in United States, Canada for the following indications:

Approved in United States as LithoVue Elite for:

• Visualization of organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae)
• Diagnostic and therapeutic procedures in the urinary tract

Approved in Canada as LithoVue Elite for:

• Visualization of organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae)
• Diagnostic and therapeutic procedures in the urinary tract

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

University of Saskatchewan

Collaborator

Trials

261

Recruited

156,000+

Findings from Research

In a study of 108 patients treated for renal stones using the single-use LithoVue™ flexible ureterorenoscope, 71.3% achieved complete stone removal in a single procedure, demonstrating its efficacy.

The device was associated with a low complication rate (7.4% of cases) and showed no significant differences in surgical outcomes between experienced consultants and less experienced residents, indicating it is user-friendly for surgeons of varying skill levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LithoVue™ for renal stone therapy - a perfect fit for high volume academic centers; a retrospective evaluation of 108 cases. Pallauf, M., Sevcenco, S., Steiner, C., et al.[2021]

The LithoVue™ single-use flexible ureteroscope demonstrated comparable or superior performance in terms of flexion, deflection, and irrigation flow compared to reusable ureteroscopes, suggesting it is an effective alternative for urological procedures.

Switching to the LithoVue could lead to significant cost savings for hospitals, with cumulative costs for reusable scopes reaching approximately $50,000, while the single-use scope could reduce expenses to around $35,000, making it a financially viable option especially in high-risk cases for scope damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-use disposable digital flexible ureteroscopes: an ex vivo assessment and cost analysis. Hennessey, DB., Fojecki, GL., Papa, NP., et al.[2019]

The LithoVue™ flexible ureteroscope demonstrated good image quality and maneuverability during a study of 40 procedures, with 65% of cases rated as having 'very good' image quality and 77.5% rated as 'very good' for maneuverability.

Despite its effectiveness, there were two instances (5%) of the LithoVue™ breaking during surgery, indicating a need for further evaluation of its durability and overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study. Doizi, S., Kamphuis, G., Giusti, G., et al.[2022]

The LithoVue single-use digital flexible ureteroscope demonstrated comparable maneuverability and visibility to conventional ureteroscopes in a study involving three surgeons testing four renal units in human cadavers.

While all ureteroscopes required a ureteral access sheath for effective kidney access, LithoVue was preferred for maneuverability in most procedures, indicating its potential utility in clinical settings, though further studies in live patients are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of New Single-Use Digital Flexible Ureteroscope Versus Nondisposable Fiber Optic and Digital Ureteroscope in a Cadaveric Model. Proietti, S., Dragos, L., Molina, W., et al.[2022]

The LithoVue single-use digital flexible ureteroscope offers significant advantages over traditional reusable ureteroscopes, including reduced costs related to repairs and reprocessing, while maintaining high image quality and flexibility for effective treatment of kidney stones.

In a case study involving a 35-year-old female patient, the LithoVue ureteroscope successfully treated lower pole kidney stones without loss of deflection, demonstrating its efficacy and reliability in a challenging clinical scenario.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impressive Performance: New Disposable Digital Ureteroscope Allows for Extreme Lower Pole Access and Use of 365 μm Holmium Laser Fiber. Leveillee, RJ., Kelly, EF.[2020]

The LithoVue™ digital flexible ureteroscope significantly reduces procedure time compared to reusable ureteroscopes, with average durations of 54.1 minutes versus 64.5 minutes, respectively, based on a study of 180 cases.

The scope failure rate for LithoVue was 4.4%, which is comparable to the 7.7% failure rate of reusable scopes, indicating that LithoVue is a safe and effective alternative for ureteroscopy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes. Usawachintachit, M., Isaacson, DS., Taguchi, K., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

LithoVue™ for renal stone therapy - a perfect fit for high volume academic centers; a retrospective evaluation of 108 cases. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Single-use disposable digital flexible ureteroscopes: an ex vivo assessment and cost analysis. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of New Single-Use Digital Flexible Ureteroscope Versus Nondisposable Fiber Optic and Digital Ureteroscope in a Cadaveric Model. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Impressive Performance: New Disposable Digital Ureteroscope Allows for Extreme Lower Pole Access and Use of 365 μm Holmium Laser Fiber. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes. [2022]